Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

Recruiting

• Conditions: Transcatheter Arterial Chemoembolization; Small Hepatocellular Carcinoma; Stereotactic Body Radiation Therapy
• Interventions: Procedure: transcatheter arterial chemoembolization

• Registration Number: NCT04161287
• Lead Sponsor: Beijing 302 Hospital

Brief Summary

The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-13
• Status Verified: 2023-03
• Primary Completion: 2023-12-11
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Study Completion: 2025-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
• single lesion and longest tumor diameter ≤ 5.0 cm
• CP-A or B classification
• Eastern Cooperative Oncology Group (ECOG) score 0-1;
• distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
• unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
• rejecting other therapies such as resection, liver transplantation, etc.
• platelet count≥50 × 109/L, white blood count≥1.5 × 109/L
• patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria

• tumor thrombus
• lymph node involvement
• extrahepatic metastasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBRT with TACE	transcatheter arterial chemoembolization	-

Primary Outcome Measures

Name	Time	Method
Local control rates	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
Overall survival rates	From date of randomization until the date of death from any cause, assessed up to 36 months	OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
Progression-free survival rates	From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months	PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.

Secondary Outcome Measures

Name	Time	Method
Radiation-induced liver injury rates	From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction	From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Trial Locations

Locations (1)

The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital); 🇨🇳 Beijing, China